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CLARITHROMYCIN IP/USP

Name: CLARITHROMYCIN IP/USP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

CLARITHROMYCIN IP/USP Specification

Heavy Metal (%)
NMT 0.001%

Particle Size
NMT 10 micron

Loss on Drying
NMT 1.0%

Molecular Formula
C38H69NO13

Residue on Ignition
NMT 0.2%

Molecular Weight
747.95 g/mol

Moisture (%)
NMT 1.0%

Assay
>=98% (HPLC)

Melting Point
225-230C (decomposes)

HS Code
29415090

Place of Origin
India

Storage
Store in a cool, dry place, protected from light

Other Names
6-O-Methylerythromycin A, Biaxin

CAS No
81103-11-9

Type
Macrolide Antibiotic

Grade
Pharmaceutical Grade

Usage
Pharmaceutical/Antibiotic API

Purity
>=98% (HPLC)

Appearance
White to off-white crystalline powder

Application
Used in the treatment of bacterial infections, respiratory tract infections, skin infections, and as an active pharmaceutical ingredient

Raw Material
Clarithromycin base

Smell
Odorless

Color
White to off-white

Form
Powder

Packaging
Fibre drum with double polyethylene bags, 10/25 kg or as required

Related Substances
NMT 1.5%

Specific Absorption
398-402 nm (in acetone)

Microbial Limits
Complies with pharmacopeial standards

Solubility
Slightly soluble in water, freely soluble in acetone and methanol

Endotoxin Level
<0.5 EU/mg

Optical Rotation
+80° to +90° (c=1, acetone)

Shelf Life
36 months from date of manufacture

Identification
IR Conforms to reference standard

About CLARITHROMYCIN IP/USP

Clarithromycin, as defined by the Indian Pharmacopoeia (IP) and United States Pharmacopeia (USP), is a potent macrolide antibiotic characterized by its white to off-white crystalline powder appearance. This antibiotic is crucial for combating bacterial infections and is formulated to meet stringent pharmacopoeial standards to ensure its purity and efficacy.

High Purity Macrolide Antibiotic API

Clarithromycin IP/USP offers pharmaceutical manufacturers a potent API with purity levels of 98% as verified by HPLC. Its molecular structure (C38H69NO13) ensures efficacy in treating multiple types of bacterial infections, making it a preferred choice for the production of advanced medications in the antibiotic category.

Reliable Quality and Compliance

Our Clarithromycin conforms to IP and USP standards, ensuring batch-to-batch consistency in quality. Each lot is subjected to rigorous analysis, including IR identification and microbial limit testing, meeting stringent international guidelines. Endotoxin levels, heavy metals, and related substances are tightly controlled to guarantee patient safety.

Flexible Packaging and Shelf Life

Available in fibre drums lined with double polyethylene bags, our Clarithromycin allows for safe, contamination-free transport and storage. With a 36-month shelf life and stable properties when stored in cool, dry conditions away from light, this API offers enhanced logistical and inventory advantages for pharmaceutical companies.

FAQ's of CLARITHROMYCIN IP/USP:

Q: How should Clarithromycin IP/USP be stored for maximum stability?

A: Clarithromycin IP/USP should be stored in a cool, dry place, protected from direct light in its original packaging. Ensuring proper storage conditions helps maintain its stability and extends its shelf life to 36 months from the date of manufacture.

Q: What are the primary uses of Clarithromycin IP/USP?

A: Clarithromycin IP/USP is mainly used as an antibiotic active pharmaceutical ingredient in the formulation of medications for treating respiratory tract infections, skin infections, and other bacterial infections.

Q: When does the product expire, and how is the shelf life determined?

A: The shelf life of Clarithromycin IP/USP is 36 months from the date of manufacture. The expiry is determined by rigorous stability testing and compliance with pharmacopeial guidelines for purity and degradation products.

Q: Where is Clarithromycin IP/USP manufactured and supplied from?

A: Clarithromycin IP/USP is manufactured, supplied, and traded from India, with packaging and logistics suitable for domestic and international pharmaceutical markets.

Q: What is the identification method used for Clarithromycin IP/USP?

A: Clarithromycin IP/USP is identified using infrared (IR) spectroscopy, conforming to the reference standard to ensure authenticity and quality.

Q: How is the quality of Clarithromycin IP/USP ensured during production?

A: Quality is controlled through multiple parameters, including HPLC assay for purity (98%), strict limits on related substances, heavy metals, and endotoxins, as well as compliance with microbial standards specified by pharmacopeias.

Q: What benefits does Clarithromycin IP/USP offer to pharmaceutical manufacturers?

A: Clarithromycin IP/USP provides reliable efficacy, high purity, compliance with international standards, flexible packaging, and a long shelf life, ensuring consistent performance in final medicinal formulations.

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